Augmenting Response to Entecavir With Peginterferon a-2a for the Treatment of HBeAg-positive Chronic Hepatitis B

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00877760
• Date of registration: 07/04/2009
• Prospective Registration: Yes
• Primary sponsor: Foundation for Liver Research
• Public title: Augmenting Response to Entecavir With Peginterferon a-2a for the Treatment of HBeAg-positive Chronic Hepatitis B ARES
• Scientific title: Augmenting Response to Entecavir Using a Temporary Peginterferon Alpha-2a add-on Strategy for the Treatment of HBeAg-positive Chronic Hepatitis B
• Date of first enrolment: August 2009
• Target sample size: 184
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00877760
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

China, Netherlands, Poland, Romania, Turkey

Contacts

• Name: Harry Janssen, Prof. dr.
• Affiliation: Foundation for Liver Research (SLO) and Erasmus Medical Center

Key inclusion & exclusion criteria

Inclusion Criteria:

- Chronic hepatitis B (HBsAg positive > 6 months)

- HBeAg positive, anti-HBe negative at screening

- ALT > 1.3 x ULN within 60 days prior to screening and during screening

- Liver biopsy performed within 2 years prior to screening or during screening

- Age > 18 years

- Written informed consent

- Adequate contraception for males and females during treatment and follow up; negative
pregnancy test (for women of childbearing potential)

Exclusion Criteria:

- Antiviral therapy against HBV within the previous 6 months

- Treatment with any investigational drug within 30 days of screening

- Previous treatment with lamivudine or telbivudine for more than six months

- Severe hepatitis activity as documented by ALT>10 x ULN

- History of decompensated cirrhosis (defined as jaundice in the presence of cirrhosis,
ascites, bleeding gastric or esophageal varices or encephalopathy)

- Pre-existent neutropenia (neutrophils < 1,500/mm3) or thrombocytopenia (platelets <
90,000/mm3)

- Co-infection with hepatitis C virus or human immunodeficiency virus (HIV)

- Other acquired or inherited causes of liver disease (i.e. alcoholic liver disease,
obesity induced liver disease, drug related liver disease, auto-immune hepatitis,
hemochromatosis, Wilson's disease or alpha-1 antitrypsin deficiency)

- Alpha fetoprotein > 50 ng/ml

- Hyper- or hypothyroidism (subjects requiring medication to maintain TSH levels in the
normal range are eligible if all other inclusion/exclusion criteria are met)

- Immune suppressive treatment within the previous 6 months

- Contra-indications for alpha-interferon therapy like suspected hypersensitivity to
interferon or PEG-interferon or any known pre-existing medical condition that could
interfere with the patient's participation in and completion of the study.

- Pregnancy, lactation

- Other significant medical illness that might interfere with this study: significant
pulmonary dysfunction in the previous 6 months, malignancy other than skin
basocellular carcinoma in previous 5 years, immunodeficiency syndromes (e.g. HIV
positivity, auto-immune diseases, organ transplants other than cornea and hair
transplant)

- Any medical condition requiring, or likely to require chronic systemic administration
of steroids, during the course of the study

- Substance abuse, such as alcohol (> 80 g/day), I.V. drugs and inhaled drugs in the
past 2 years.

- Any other condition which in the opinion of the principal investigator would make the
patient unsuitable for enrollment, or could interfere with the patient participating
in and completing the study



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Hepatitis B

Intervention(s)

Drug: pegylated interferon a-2a

Drug: Entecavir

Primary Outcome(s)

The combined presence of HBV DNA level < 200 IU/mL and HBeAg loss [Time Frame: week 48]

Secondary Outcome(s)

HBsAg and HBeAg loss from serum [Time Frame: up to week 96]

Undetectable HBV DNA <60 IU/mL [Time Frame: up to week 96]

The emergence of HBV polymerase mutations associated with reduced susceptibility to entecavir [Time Frame: up to week 96]

ALT normalization [Time Frame: up to week 96]

Sustained response defined as the combined presence of HBV DNA level < 200 IU/mL and HBeAg loss [Time Frame: week 96]

Secondary ID(s)

HBV 09-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors